Licensing Strategies for Accessing Biomarker Technologies

Published by: Decision Resources

Published: Dec. 7, 2007 - 28 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Advantages of Biomarkers Across the Health Care Value Chain

Accessing Biomarker Technology

Where Do Novel Biomarkers Come From?

Fitness-for-Purpose

Biomarkers in Biopharmaceutical and Diagnostics Companies

Biomarker Use in Biopharmaceutical Companies

Biomarker Use in Diagnostics Companies

Biomarker Licensing Activities by IVD Companies

Role of Smaller Companies in Biomarker Research

Testing Lab Companies

Biomarker Research Tool and Service Companies

Tapping Research Institutions and Universities

Commercialization of Biomarker Technologies

Operations

Royalty Rates

Milestone Payments

Continuing Support

Personal Contacts

Importance to Emerging Diagnostics and Biotechnology Companies

Outlook

Engine for New Biomarkers

Funding Is Critical

Sidebar

Consortia Addressing Biomarker Usage for Drug Discovery and Development

Tables

1. Uses of Biomarkers in Drug Discovery and Development

2. Biomarker Defi nitions for Drug Discovery and Development

3. Key Biomarker Outlicensing Agreements Among Biopharmaceutical Companies, January 2006-October 2007

4. Select Outlicensing Biomarker Technology Deals by IVD Companies, July 2006- October 2007

5. Key Biomarker Licensing Activities Among Smaller Companies, January 2007- October 2007

6. New Biomarker Technology Agreements with Testing Lab Companies, July 2006- October 2007

7. Select Biomarker Research Service and Tools Companies

8. Major Considerations in Technology Transfer Deals

9. Select Biomarker Outlicensing Activities by Research Institutions and Universities, January 2006-October 2007

Figures

1. Requirements for Validation and Qualifi cation in Biomarker Discovery and Development

2. Number of FDA-Approved New Molecular Entities (NMEs) (1997-2006) and Total Global R&D Spending, PhRMA Members (1997-2005)

Abstract

• Biopharmaceutical companies must carefully consider their options when seeking to access specifi c biomarker •
technology. What single principle should biopharmaceutical companies adhere to when seeking to secure successful deals with potential clients in order to increase the chances of fi nding a suitable partner?
• In today’s environment of M&As and the anticlimactic results of the Roche-Ventana and GE Healthcare-Ab- •
bott deals, large in vitro diagnostics (IVD) companies need to clarify their biomarker research strategies. How should a large IVD company’s choice of commercial partners change with the company’s goals?
• Research institutions and universities that have patented technology will continue to rely upon licensees or •
commercial partners to further refi ne the technology and perform the advanced testing that allows commercial use of the technology. What aspect of licensing agreements do research institutions need to be particularly wary of when negotiating agreements with commercial partners?
• Because the bulk of new biomarker research is driven by research institutions and universities, these parties •
need to continue to secure funding for their research efforts. Why is reliance on biopharmaceutical licensing partnerships as a source of funding for these institutions particularly risky in today’s biomarker environment?
• Partly because of the costs associated with biomarker development, several consortia have been set up to •
address biomarker use for drug discovery and development. What specifi c biomarkers are some of these consortia seeking to develop?

• Advantages of biomarkers across the health care value chain: • benefi ts for diagnostics companies,
biopharmaceutical companies, life sciences research tools companies, patients, caregivers, and health care payers
• Accessing biomarker technology: • sources of biomarkers; determining biomarker access strategies;
validation and qualifi cation requirements
• Research institutions and universities: • goals of outlicensing biomarker technology; the transference
of technology to the private sector; patents, royalties, liabilities, and milestone payments; commercialization of biomarker technology; importance to emerging diagnostics and biotechnology companies
• Biopharmaceutical and diagnostics companies: • the use of biomarkers as tools for improving drug
discovery and development; association with diagnostics testing companies; biomarker licensing activities by in vitro diagnostics companies
• Smaller companies: • the role of testing laboratory companies and biomarker research tool and service
companies
• Licensing agreements: • a series of 5 tables detailing more than 170 biomarker agreements
• Outlook: • the engine for new biomarkers; providing critical funding; consortia to the rescue

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